Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

PHASE2UnknownINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

February 28, 2018

Study Completion Date

April 30, 2018

Conditions
CML, Chronic Phase
Interventions
DRUG

Inecalcitol

Prospective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib.

Trial Locations (1)

14033

RECRUITING

CHU Côte de Nacre, Caen

Sponsors
All Listed Sponsors
lead

Hybrigenics Corporation

INDUSTRY